Immediate ImplantNCT06642753
Buccal Plate Augmentation Using Sticky Bone With Simultaneous Immediate Implant Placement
A study testing immediate implant with buccal plate augmentation using sticky bone and immediate implant with sticky bone as a filling material in the jumping gap in people with Immediate Implant, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is to clinically assess pink esthetic score following Buccal Plate Augmentation using Sticky Bone versus usage of Sticky Bone as a jumping gap filling material with simultaneous immediate implant placement in the maxillary esthetic zone Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant
- What is being tested?
- immediate implant with buccal plate augmentation using sticky bone and immediate implant with sticky bone as a filling material in the jumping gap
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Presence of a non-restorable maxillary tooth in the esthetic zone including maxillary anteriors and premolars indicated for extraction.
- An intact buccal plate of bone after extraction.
- Full-mouth plaque and bleeding score not exceeding 20%.
- Patients showing motivation to comply with post-operative care instructions and follow- up appointments.
Who cannot join
- Periapical infection involving the tooth to be extracted.
- Periodontal disease
- Systemic health conditions that contraindicate or affect healing of implant surgery (Diabetes Mellitus, Leukemia)
- Pregnant and nursing females.
- Smokers
Trial locations and contacts
1 site in 1 country.
Enji ahmed, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo, 12613
About this study
Official title: Buccal Plate Augmentation Using Sticky Bone Versus Usage of Sticky Bone as a Jumping Gap Filling Material With Simultaneous Immediate Implant Placement in the Maxillary Esthetic Zone :A Randomized Controlled Clinical Trial
the aim of this study is to clinically assess pink esthetic score following Buccal Plate Augmentation using Sticky Bone versus usage of Sticky Bone as a jumping gap filling material with simultaneous immediate implant placement in the maxillary esthetic zone
Read the detailed description
All patients will undergo pre-operative clinical examination: Patient's data will be collected; name, gender and age, medical and dental histories will be taken. Also, all patients will undergo standardized periapical radiograph to detect any pathosis and a pre-operative Cone beam computed tomography (CBCT) scans will be taken to evaluate the tooth root configuration and to confirm the presence of intact buccal wall, Vital structures related to the tooth, Vertical and horizontal dimensions of the alveolar bone and Bone density.
Patient preparation for surgical procedure:
After extra oral disinfection of the surgical site ,the patients will be asked to rinse their mouths with Chlorohexidine HCL 1.25% mouthwash (Orovex mouthwash, Macro group, Egypt) immediately preoperatively. Local infiltration anesthesia [Articaine 4% 1:100,000 epinephrine] (Artinibsa 40mg/0.1 mg/Ml ˗ epinephrine 1:100000, Spain) will be used for all procedures.
Control group:
- The surgical procedure will be performed in sterile surgical field. Under local anesthesia, sharp dissection of the supracrestal fibers will be done with no.15 c scalpel blade. With the purpose of preserving the buccal and palatal bone walls, periotomes, elevators and maxillary root forceps will be used to facilitate atraumatic extraction.
- The socket will be well irrigated with saline and debrided with a bone curette. An intact buccal bone plate should be found after extraction of the tooth.
- Bony sockets will be prepared through sequential drilling for the placement of the implant.
- Achieving primary stability after implant placement will be followed by placement of cover screw.
- Venous blood will be withdrawn under aseptic conditions by veni puncture of the antecubital vein and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
- Plastic PET tubes to create Liquid-PRF, while glass tubes will be used to obtain Solid-PRF.
- Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug.
- Blood will be centrifuged at a speed of 700 rpm for 3 minutes. An orange- colored fluid will be formed as the upper layer in the test tubes i.e., I- PRF. Approximately 1 ml of I-PRF will be collected in a syringe.
- Solid-PRF + Liquid-PRF mixed DBBM: Solid-PRF membranes will be cut into small PRF fragments sized between 1-2 mm and mixed thoroughly with 0.25 g of DBBM particles. Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM.
- Following polymerization by 15-20 minutes, sticky bone will be ready to be grafted.
- The sticky bone graft will be condensed and adapted into the jumping gap as well as over the implants. Further, it will be covered with PRF membrane.
- the healing abutment will be screwed into the implant body .
Intervention group:
- A thin periosteal elevator will be used to reflect the soft tissue buccal to the bony buccal plate on the mid-facial aspect of the socket in a full-thickness manner, following a corono-apical direction, thereby creating a 'surgical pouch.
- The dissection will be advanced beyond the mucogingival line to approximately two-thirds the depth of the socket, and the 'pouch' will be expanded in the mesio-distal direction to stretch the soft tissues away from the underlying bony plate.
- Sticky bone will be inserted into the pouch by a mean of a small periosteal elevator. Additional graft material will be added and compressed until adequate filling of the pouch is achieved without overstretching the soft tissues.
- the healing abutment will be screwed into the implant body .
- Conditions
- Immediate Implant
- Being tested
- immediate implant with buccal plate augmentation using sticky bone, immediate implant with sticky bone as a filling material in the jumping gap
- Keywords
- buccal plate preservation, sticky bone, PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant with buccal plate augmentation using sticky boneBiological
- Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
- Plastic PET tubes to create Liquid-PRF, while glass tubes will be used to obtain Solid-PRF.
- Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug.
- Blood will be centrifuged at a speed of 700 rpm for 3 minutes. An orange- colored fluid will be formed as the upper layer in the test tubes i.e., I- PRF. Approximately 1 ml of I-PRF will be collected in a syringe.
- Solid-PRF + Liquid-PRF mixed DBBM: Solid-PRF membranes will be mixed thoroughly with 0.25 g of DBBM particles. Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM.
- Following polymerization by 15-20 minutes, sticky bone will be ready to be grafted in the pouch .
immediate implant with sticky bone as a filling material in the jumping gapBiological
Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
- Plastic PET tubes to create Liquid-PRF, while glass tubes will be used to obtain Solid-PRF.
- Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug.
- Blood will be centrifuged at a speed of 700 rpm for 3 minutes. An orange- colored fluid will be formed as the upper layer in the test tubes i.e., I- PRF. Approximately 1 ml of I-PRF will be collected in a syringe.
- Solid-PRF + Liquid-PRF mixed DBBM: Solid-PRF membranes will be mixed thoroughly with 0.25 g of DBBM particles. Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM.
- Following polymerization by 15-20 minutes, sticky bone will be ready to be grafted in the jumping gap.
| Study group | Role | What they receive |
|---|---|---|
| immediate implant with buccal plate augmentation using sticky bone | Experimental | atraumatic extraction.
* The socket will be well irrigated with saline and debrided with a bone curette.
* placement of the implant.
* Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
* sticky bone will be ready to be grafted.
* Sticky bone will be inserted into the pouch by a mean of a small periosteal elevator. Additional graft material will be added and compressed until adequate filling of the pouch is achieved without overstretching the soft tissues.
* the healing abutment will be screwed into the implant body . Receives: Biological: immediate implant with buccal plate augmentation using sticky bone |
| immediate implant with sticky bone as a filling material in the jumping gap | Active comparator | * atraumatic extraction.
* The socket will be well irrigated with saline and debrided with a bone curette.
* placement of the implant.
* Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
* sticky bone will be ready to be grafted.
* The sticky bone graft will be condensed and adapted into the jumping gap as well as over the implants. Further, it will be covered with PRF membrane.
* the healing abutment will be screwed into the implant body Receives: Biological: immediate implant with sticky bone as a filling material in the jumping gap |
What is being measured
The primary outcome is the main question the study is designed to answer.
pink esthetic score
This pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency .With the exception of papilla formation, the evaluation is performed visually by comparing reference teeth (i.e., with the contralateral tooth in the incisor zone and adjacent tooth in the premolar zone). For the mesial and distal papilla, the categories are complete, incomplete, and absent. For each criterion it is possible to award a score between two points (for a very good outcome) and no points (for a poor outcome). The maximum score that can be achieved is 14 points indicating an outcome that reflects complete conformity between the soft tissue of the tooth being assessed and that of the reference tooth.
Measured: 3 and 6 months postoperative
Secondary outcomes (4)
crestal bone level
using Cone beam computed tomography (CBCT) machine with superimposition technique.
Measured: baseline and 6 months post operative
Thickness of labial plate of bone
Using CBCT machine . Using the axial view, one reference line will be drawn from the apex of the implant to its platform (long axis); another line, perpendicular to the one at the long axis, will be drawn at the apex of the implant. Parallel to this, two lines will be drawn, one at 1 mm from the implant collar (R1) and another 5 mm apical to it (R2) measuring the thickness of the bone (at the buccal plate) to the nearest 0.1 mm.
Measured: baseline and 6 months postoperatively
Soft tissue profile /contour
Scanning of diagnostic casts by optical scanner.
Measured: baseline, 3 and 6 months postoperatively.
patient satisfaction
VAS (Visual analogue scales ) based questionnaire. for pain: The most common VAS consists of a 10-cm horizontal or vertical line with the two endpoints labeled "no pain" and "worst pain ever" (or similar verbal descriptors). The patient is required to place a mark on the 10-cm line at a point that corresponds to the level of pain intensity they presently feel. The distance in centimeters from the low end of the VAS to the patient's mark is used as a numerical index of the severity of pain.
for swelling:
- no swelling.
- mild intraoral swelling
- moderate intraoral swelling
- severe extraoral swelling
Measured: immediately after implant placement , 3 and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate ImplantStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Khaled Mahmoud Khalefa Ghaith, Cairo University
- Investigators
- Enji ahmed, professor, Study director, Cairo Universityshaimaa Nasr, Ass. Prof, Study chair, Cairo UniversityYara Kh Ghaith, Bachelor, Principal investigator, Cairo Universitysamah bahaa, Lecturer, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642753
- Sponsor's protocol ID
- PER.6-3-1
- Status last verified
- Sep 2024
- First submitted
- 5 Aug 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Plate Augmentation Using Sticky Bone Versus Usage of Sticky Bone as a Jumping Gap Filling Material With Simultaneous Immediate Implant Placement in the Maxillary Esthetic Zone :A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06642753
- Acronym / sponsor ID
- PER.6-3-1
- Conditions
- Immediate Implant
- Keywords
- buccal plate preservation, sticky bone, PRF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the aim of this study is to clinically assess pink esthetic score following Buccal Plate Augmentation using Sticky Bone versus usage of Sticky Bone as a jumping gap filling material with simultaneous immediate implant placement in the maxillary esthetic zone
Detailed description
All patients will undergo pre-operative clinical examination: Patient's data will be collected; name, gender and age, medical and dental histories will be taken. Also, all patients will undergo standardized periapical radiograph to detect any pathosis and a pre-operative Cone beam computed tomography (CBCT) scans will be taken to evaluate the tooth root configuration and to confirm the presence of intact buccal wall, Vital structures related to the tooth, Vertical and horizontal dimensions of the alveolar bone and Bone density.
Patient preparation for surgical procedure:
After extra oral disinfection of the surgical site ,the patients will be asked to rinse their mouths with Chlorohexidine HCL 1.25% mouthwash (Orovex mouthwash, Macro group, Egypt) immediately preoperatively. Local infiltration anesthesia [Articaine 4% 1:100,000 epinephrine] (Artinibsa 40mg/0.1 mg/Ml ˗ epinephrine 1:100000, Spain) will be used for all procedures.
Control group:
- The surgical procedure will be performed in sterile surgical field. Under local anesthesia, sharp dissection of the supracrestal fibers will be done with no.15 c scalpel blade. With the purpose of preserving the buccal and palatal bone walls, periotomes, elevators and maxillary root forceps will be used to facilitate atraumatic extraction.
- The socket will be well irrigated with saline and debrided with a bone curette. An intact buccal bone plate should be found after extraction of the tooth.
- Bony sockets will be prepared through sequential drilling for the placement of the implant.
- Achieving primary stability after implant placement will be followed by placement of cover screw.
- Venous blood will be withdrawn under aseptic conditions by veni puncture of the antecubital vein and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
- Plastic PET tubes to create Liquid-PRF, while glass tubes will be used to obtain Solid-PRF.
- Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug.
- Blood will be centrifuged at a speed of 700 rpm for 3 minutes. An orange- colored fluid will be formed as the upper layer in the test tubes i.e., I- PRF. Approximately 1 ml of I-PRF will be collected in a syringe.
- Solid-PRF + Liquid-PRF mixed DBBM: Solid-PRF membranes will be cut into small PRF fragments sized between 1-2 mm and mixed thoroughly with 0.25 g of DBBM particles. Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM.
- Following polymerization by 15-20 minutes, sticky bone will be ready to be grafted.
- The sticky bone graft will be condensed and adapted into the jumping gap as well as over the implants. Further, it will be covered with PRF membrane.
- the healing abutment will be screwed into the implant body .
Intervention group:
- A thin periosteal elevator will be used to reflect the soft tissue buccal to the bony buccal plate on the mid-facial aspect of the socket in a full-thickness manner, following a corono-apical direction, thereby creating a 'surgical pouch.
- The dissection will be advanced beyond the mucogingival line to approximately two-thirds the depth of the socket, and the 'pouch' will be expanded in the mesio-distal direction to stretch the soft tissues away from the underlying bony plate.
- Sticky bone will be inserted into the pouch by a mean of a small periosteal elevator. Additional graft material will be added and compressed until adequate filling of the pouch is achieved without overstretching the soft tissues.
- the healing abutment will be screwed into the implant body .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant with buccal plate augmentation using sticky bone | Experimental | Biological: immediate implant with buccal plate augmentation using sticky boneatraumatic extraction. * The socket will be well irrigated with saline and debrided with a bone curette. * placement of the implant. * Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al. * sticky bone will be ready to be grafted. * Sticky bone will be inserted into the pouch by a mean of a small periosteal elevator. Additional graft material will be added and compressed until adequate filling of the pouch is achieved without overstretching the soft tissues. * the healing abutment will be screwed into the implant body . |
| immediate implant with sticky bone as a filling material in the jumping gap | Active comparator | Biological: immediate implant with sticky bone as a filling material in the jumping gap* atraumatic extraction. * The socket will be well irrigated with saline and debrided with a bone curette. * placement of the implant. * Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al. * sticky bone will be ready to be grafted. * The sticky bone graft will be condensed and adapted into the jumping gap as well as over the implants. Further, it will be covered with PRF membrane. * the healing abutment will be screwed into the implant body |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older.
- Presence of a non-restorable maxillary tooth in the esthetic zone including maxillary anteriors and premolars indicated for extraction.
- An intact buccal plate of bone after extraction.
- Full-mouth plaque and bleeding score not exceeding 20%.
- Patients showing motivation to comply with post-operative care instructions and follow- up appointments.
Key exclusion criteria (5 listed)
- Periapical infection involving the tooth to be extracted.
- Periodontal disease
- Systemic health conditions that contraindicate or affect healing of implant surgery (Diabetes Mellitus, Leukemia)
- Pregnant and nursing females.
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immediate implant with buccal plate augmentation using sticky bone* Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al. * Plastic PET tubes to create Liquid-PRF, while glass tubes will be used to obtain Solid-PRF. * Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug. * Blood will be centrifuged at a speed of 700 rpm for 3 minutes. An orange- colored fluid will be formed as the upper layer in the test tubes i.e., I- PRF. Approximately 1 ml of I-PRF will be collected in a syringe. * Solid-PRF + Liquid-PRF mixed DBBM: Solid-PRF membranes will be mixed thoroughly with 0.25 g of DBBM particles. Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM. * Following polymerization by 15-20 minutes, sticky bone will be ready to be grafted in the pouch . | Biological | immediate implant with buccal plate augmentation using sticky bone |
| immediate implant with sticky bone as a filling material in the jumping gapVenous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al. * Plastic PET tubes to create Liquid-PRF, while glass tubes will be used to obtain Solid-PRF. * Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug. * Blood will be centrifuged at a speed of 700 rpm for 3 minutes. An orange- colored fluid will be formed as the upper layer in the test tubes i.e., I- PRF. Approximately 1 ml of I-PRF will be collected in a syringe. * Solid-PRF + Liquid-PRF mixed DBBM: Solid-PRF membranes will be mixed thoroughly with 0.25 g of DBBM particles. Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM. * Following polymerization by 15-20 minutes, sticky bone will be ready to be grafted in the jumping gap. | Biological | immediate implant with sticky bone as a filling material in the jumping gap |
Primary outcome
pink esthetic score
Time frame: 3 and 6 months postoperative
This pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency .With the exception of papilla formation, the evaluation is performed visually by comparing reference teeth (i.e., with the contralateral tooth in the incisor zone and adjacent tooth in the premolar zone). For the mesial and distal papilla, the categories are complete, incomplete, and absent. For each criterion it is possible to award a score between two points (for a very good outcome) and no points (for a poor outcome). The maximum score that can be achieved is 14 points indicating an outcome that reflects complete conformity between the soft tissue of the tooth being assessed and that of the reference tooth.
4 secondary outcomes
crestal bone level
Time frame: baseline and 6 months post operative
Thickness of labial plate of bone
Time frame: baseline and 6 months postoperatively
Soft tissue profile /contour
Time frame: baseline, 3 and 6 months postoperatively.
patient satisfaction
Time frame: immediately after implant placement , 3 and 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enji ahmed, Professor contact
Enji ahmed, professor study director
Cairo University
shaimaa Nasr, Ass. Prof study chair
Cairo University
Yara Kh Ghaith, Bachelor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant with buccal plate augmentation using sticky bone and immediate implant with sticky bone as a filling material in the jumping gap in people with Immediate Implant, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yara KH Ghaith (01025718437, yara.khalefa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pink esthetic score (time frame: 3 and 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.